The new study, led by M.D. Anderson radiation oncologist Elizabeth S. Bloom, M.D., is consistent with these results. The patient in the case report tolerated the treatment well and the device was removed without complication.
An examination eight weeks after treatment revealed no palpable seroma (a potential complication of radiation therapy). At the six-month follow-up examination, the cosmetic outcome was rated excellent according to the Harvard scale. There was no evidence of cancer recurrence as determined by both physical examination and diagnostic mammogram.
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Based on their experience with this patient plus previous studies of SAVI, the authors stated that patients should not be excluded from SAVI because of non-tumor-related issues such as breast size, the spacing of the surgical cavity in relation to the skin or ribs, or the presence of breast implants. They also noted that "The APBI brachytherapy method with the greatest versatility in dosimetric coverage and the best ability to limit the dose to normal structures is multicatheter brachytherapy."
SAVI is currently used with the majority of APBI cases at M.D. Anderson.
SAVI is a multicatheter brachytherapy device. It is also the only single-entry breast brachytherapy device that allows physicians to customize radiation based on patient-specific anatomy. Clinical studies show this unique ability can make the benefits of APBI available to twice as many women, as well as result in better outcomes including less skin toxicity, reduced risk of infection and improved cosmesis.
A video featuring a SAVI patient with breast implants can be viewed here. The patient in the video is not the patient who was the subject of the study published in Brachytherapy.
About Cianna Medical, Inc.
Cianna Medical, Inc. is a medical device company focused on women's health and dedicated to the innovative treatment of early-stage breast cancer. The company manufactures and markets the SAVI breast brachytherapy applicator, for the delivery of radiation after lumpectomy surgery. The SAVI applicator allows precise sculpting of the radiation dose, and is designed to make the benefits of accelerated partial breast irradiation available to a greater number of women.
For more information, call (toll-free) 866-920-9444 or visit www.ciannamedical.com/.
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